Drug Recall Notice Template

[Name of Manufacturer / Marketing Company]
[Full Address]
Mfg. Licence No.: [Form 25/28 Licence No.]   |   Tel: [___]

Ref: RECALL/[Year]/[Serial No.]                    URGENT — DRUG RECALL
Recall Classification: [Class I / Class II / Class III]
Date: [DD/MM/YYYY]

To,
All Distributors, Stockists, Wholesalers, Retailers, Hospitals and
Institutions handling the product listed below.

(Copy to: Central Drugs Standard Control Organisation (CDSCO) and the
 State/Zonal Drugs Controller of [State].)

Subject: RECALL of [Product / Brand Name] — Batch No. [___] due to
         [reason — e.g. Not of Standard Quality / failing [test]].

Dear Sir / Madam,

We hereby notify an immediate recall of the following drug product from
the market. You are requested to STOP SALE / DISTRIBUTION forthwith,
quarantine all stock, and return it as per instructions below.

  PRODUCT DETAILS
  -------------------------------------------------------------------
  Product / Brand name  : [Name]
  Generic / Composition : [Salt & strength]
  Dosage form           : [Tablet / Injection / Syrup]
  Batch / Lot No.       : [___]
  Mfg. Date             : [MM/YYYY]
  Expiry Date           : [MM/YYYY]
  Batch size / Qty      : [___]
  Mfg. Licence No.      : [___]
  MRP                   : ₹[___]
  -------------------------------------------------------------------

  REASON FOR RECALL : [e.g. Declared "Not of Standard Quality" by
  Government Analyst vide report No. [___]; failing in
  Assay / Dissolution / Sterility / labelling defect / suspected
  spurious as per Section 17/17A/17B of the Drugs & Cosmetics Act,
  1940.]

  RECALL LEVEL      : [Consumer / Retail / Wholesale level]
  RISK              : [Describe potential health hazard]

ACTION REQUIRED BY RECIPIENTS:
  1. Immediately stop sale, distribution and dispensing of the above
     batch.
  2. Physically segregate and quarantine all stock of the said batch
     and label it "RECALLED — NOT FOR SALE".
  3. Complete the enclosed Recall Return / Reconciliation Form stating
     quantity received, sold and in hand, and return it to us within
     [__] days.
  4. Return the recalled stock to [return address / our representative]
     for [replacement / credit note / destruction] against proper
     documentation.
  5. Forward this notice to any sub-stockist / customer to whom you
     have further distributed the batch.

We are simultaneously reporting this recall to the CDSCO and the
concerned State Drugs Control Authority and shall carry out a recall
effectiveness check and reconciliation.

For any clarification, contact our Recall Coordinator:
  Name: [___]   |   Mobile: [___]   |   Email: [___]

We regret the inconvenience and seek your fullest cooperation in the
interest of patient safety.

Yours faithfully,
For [Name of Company],

____________________________
([Name])
Authorised Signatory / Quality Head
[Designation]

Enclosure: Recall Return & Reconciliation Form.